RecruitingNot ApplicableNCT06641778

Fecal Microbiota Transplantation in Patients With Multiple Drug Resistant Klebsiella Pneumoniae Pneumonia


Sponsor

luxia Kong

Enrollment

100 participants

Start Date

Dec 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Multidrug-resistant Klebsiella pneumoniae (MDR-KP) infections account for 10% of all nosocomial infections, and even with effective antibiotics, the mortality rate is as high as 50%. Intestinal bacteria transplantation can not only treat intestinal diseases, but also inhibit the colonization and proliferation of drug-resistant bacteria. This study explored the therapeutic value of fecal microbiota transplantation in patients with MDR-KP pneumonia.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • Age 18-75;
  • Meet the diagnostic criteria for community-acquired pneumonia or hospital-acquired pneumonia;
  • The etiological results of sputum or alveolar lavage fluid suggested MDR-KP infection;
  • The patient or his family members voluntarily participated, collected alveolar lavage fluid and stool samples, agreed to perform FMT treatment, and signed the informed consent.

Exclusion Criteria12

  • Subjects with persistent bronchial asthma, severe pulmonary dysfunction, or inability to tolerate bronchoscopy;
  • Patients with severe damage of intestinal barrier such as sepsis and digestive tract perforation due to various reasons;
  • Those currently diagnosed with explosive colitis or toxic megacolon have gastroesophageal reflux disease or peptic ulcer; Subjects taking probiotics within 6 months;
  • Enteral nutrition patients who could not tolerate 50% of heat calorie requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula and other reasons.
  • Patients with obvious bleeding tendency, severe pulmonary hypertension, superior vena cava obstruction, and aortic aneurysm rupture risk;
  • Patients with malignant hypertension, recent myocardial infarction (≤6 months), severe arrhythmia, and cardiac insufficiency;
  • suffering from malignant tumor diseases, congenital or acquired immune deficiency diseases, other systemic inflammatory response diseases;
  • Those who have recently been treated with high-risk immunosuppressive/cytotoxic drugs, such as rituximab, doxorubicin, or steroid hormones (20mg/d ponisone or higher) for more than 4 weeks;
  • Severe immunosuppression: adult neutrophils <1 500/mm3, child neutrophils <1 000/mm3;
  • Pregnancy or lactation;
  • There is a mental disability or active mental illness that prevents informed consent;
  • Conditions deemed unsuitable for study inclusion by other clinicians.

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Interventions

OTHERFecal Microbiota Transplantation

Patients in the experimental group received conventional antibiotic therapy plus fecal microbiota transplantation, and the efficacy was compared with that in the control group


Locations(1)

The central Hospital of Wuhan

Wuhan, Hubei, China

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NCT06641778